FDA.reportPublic FDA data

NOIR

Primary DI
04046963386047
Brand
NOIR
Company
Aesculap AG
Model
FF590B
Catalog number
FF590B
Device description
NOIR TRANSSPHENOIDAL SPECULA 90X13MM
Published
2020-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPYSPECULUM, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963386047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963386047040469633860474046963386047

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809991035006Shim SPOTDOCTORSHIM KOREA INC.EPY2026-07-10
00850083275808Intrace USAPILOTIS TECH LLCEPY2026-07-03
00850083275815Intrace USAPILOTIS TECH LLCEPY2026-07-03
00850083275877Intrace USAPILOTIS TECH LLCEPY2026-07-03
00810158216594PRINCETONPrinceton Medical Group, Inc.EPY2026-06-23
00810189451704Surgical DesignSurgical Design, Inc.EPY2026-06-10
09348811148858INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148889INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148957INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148919INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
09348811148933INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
G043714000BEARBear-Ent, LLCEPY2026-05-07
G04371401G0GEIZBear-Ent, LLCEPY2026-05-07
G04371402G0GEIZBear-Ent, LLCEPY2026-05-07
G04371403G0GEIZBear-Ent, LLCEPY2026-05-07
09348811116673INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-04-24
09348811116925INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-03-18
09348811116345INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116369INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116383INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116406INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116413INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811148995INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
08906039319514OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319521OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319538OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319545OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
04250407704490FENTEXFENTEX medical GmbHEPY2022-12-07
04250407704766FENTEXFENTEX medical GmbHEPY2022-12-07
04250407704780FENTEXFENTEX medical GmbHEPY2022-12-07